Institutional Review Board Application Process
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April 06, 2023
Maya Monges-Hernandez, CIP
IRB Administrator
Bonny Burn-Whitmore,
IRB Chair, RD, DrPH
Office of Research Compliance
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Institutional Review Boards
Institutional Review Boards
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Is it Research with human subjects?
Research
means a systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge.
Human subject
means a living individual about whom an investigator
(whether professional or student) conducting research:
1.
(i) Obtains information or biospecimens through intervention or interaction
with the individual, and uses, studies, or analyzes the information or
biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private
information or identifiable biospecimens.
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Encourage research participation
Conduct yourself with integrity
Follow University policy and sponsor conditions
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The Cal Poly Pomona IRB
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The Committee
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Bonny Burns- Whitmore, IRB Co-Chair
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Greg Placentia, IRB Co-Chair
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Members
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Faculty with various backgrounds and expertise
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One nonaffiliated member
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One Nonscientist
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Qualified by education, training, and/or experience
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Recent f
amiliarity and experience with the topic of study
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IRB investigator
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Principal Investigator or Co-PI
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Getting started with a new protocol
( Faculty Information sheet)
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Some projects involve activities that require specialized
review outside of the IRB
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Research Site Authorizations
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Departmental Access to
D
ata
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Registrars' office-
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FERPA
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Library deadlines
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Types of Review
Exempt
Anonymous or identifiable surveys or interviews – less than minimal risk
Expedited
Collection of data from voice, video- less or greater than minimal risk
Full board
P
resent more than minimal risks to subjects
Studies involving prisoners, persons with undocumented status, research on
illegal activities, incarcerated youth, among others
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What must be included in the IRB protocol application
“Confidential”
research participation means that the data from the research subject(s)
can
potentially be identified or linked to a particular individual. Thus,
any
data collected face-to-face
(consumer survey, focus groups, standing in front of a classroom, collecting IP addresses, etc.) is
automatically considered in the category of being “confidential”
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“strictly anonymous”
study design is one in which it is impossible to trace data or information
back to the research subject from whom it was obtained. In other words, the data
cannot
be
identified to any research participant, not even by the researcher.
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Methods
Summarize the overall
design
of your proposed study
Procedures involving human subjects, including participant
observation, as well as up to 100 semi-structured interviews and life
histories, will examine the perceived risks or benefits for local
community members of proposed mining development projects, as
well as past experiences with social and environmental systems
under stress from anthropogenic changes to land, territory and
resources. The new Lithium Valley project at the Salton Sea, offers an
opportunity to lead students in ethnographic field training that
combines community-based action research with citizen science.
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Subject and Recruitment
A human subject is a living individual about whom an investigator (whether professional or
student) conducting research obtains data through intervention or interaction with the individual
or identifiable private information. (Dept. of Health and Human Services, 45CFR46)
Describe the
characteristics
of the subject group(s) that will be used in the study.
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Participants in the study will include Indigenous people, activists,
residents, squatters, as well as migrant farmworkers and geothermal
plant operators who are 18 years old or older. The subject pool will
include members of the California Energy Commission's Lithium Valley
Commission, as well as other stakeholders, decision-makers and experts
on the role of mining in the energy transition more broadly.
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Data Security
The researcher must provide a plan sufficient to protect personal information from improper use
and disclosures, including sufficient administrative, physical, and technical safeguards to protect
personal information from reasonable anticipated threats to the security or confidentiality of the
information.
A
strictly anonymous
study design is one in which it is impossible
to trace data or information back to the research subject from
whom it was obtained. In other words, the data
cannot
be
identified to any research participant, not even by the researcher.
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Elements of informed consent include …
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Explanation of the purpose(s)
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Description of the procedure(s)
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Summary of the data to be collected
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Description of any foreseeable risks/ discomforts
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Description of the benefits to the subject/ including compensation.
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Explanation of how the investigator (PI) will maintain
confidentiality of records.
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Contact information of
all
PI’s and the IRB office, protocol number
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A statement that participation is voluntary, that refusal to participate
involves no penalty and that the subject may discontinue at any
time.
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Anything else that will help the subject to understand.
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Subject Librarians
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https://www.cpp.edu/library/reference-instruction/contact-subject-
librarian.shtml
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https://libguides.library.cpp.edu/datamgmt
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Workshops (citation, Topic/Research areas and methods)
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Library Calendar:
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https://cpp.libcal.com/
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Writing
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enter
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Website:
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https://www.cpp.edu/lrc/our-team/writing-center.shtml
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Bronco Scholar
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FAQ's:
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https://www.cpp.edu/library/digital-collections/bronco-scholarworks/faq.shtml
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Qualtrics
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https://www.cpp.edu/cba/customer-insights-lab/resources/qualtrics.shtml
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Follow a timeline to ensure you are on track…
Encourage research participation
Conduct yourself with integrity
Follow University policy and sponsor conditions
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Questions?
More info:
Human subject research
https://www.cpp.edu/research/research-compliance/index.shtml
IRB protocol application process
https://www.cpp.edu/research/research-
compliance/irb/protocol.shtml
Irb-office@cpp.edu
or 909-869-4215
www.hhs.gov/ohrp/
Members of the IRB- Your college or discipline representative
The basics of the IRB, researcher responsibilities, IRB members, and the role of faculty advisors and student investigators in navigating the IRB application process. Understand the importance of ancillary approvals for research projects involving human subjects.
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Presentation Transcript
Office of Research Compliance Institutional Review Board Application Process April 06, 2023 Maya Monges-Hernandez, CIP IRB Administrator Bonny Burn-Whitmore, IRB Chair, RD, DrPH
Learning Objectives Purpose of the Institutional Review Board- Basics The research process and ancillary approval Protocol process and navigating the Cayuse IRB platform Adequate Resources to Conduct Research
Basics of the IRB Institutional Review Boards
Basics of the IRB Is it Research with human subjects? Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator (whether professional or student) conducting research: 1.(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
CPP Researcher Responsibility Encourage research participation Conduct yourself with integrity Follow University policy and sponsor conditions
IRB Members The Cal Poly Pomona IRB The Committee Bonny Burns-Whitmore, IRB Co-Chair Greg Placentia, IRB Co-Chair Members Faculty with various backgrounds and expertise One nonaffiliated member One Nonscientist
Faculty Advisor and Student Investigator Qualified by education, training, and/or experience Recent familiarity and experience with the topic of study IRB investigator Principal Investigator or Co-PI Getting started with a new protocol ( Faculty Information sheet)
Faculty Advisor and Student Investigator
Understanding Ancillary Approvals Some projects involve activities that require specialized review outside of the IRB Research Site Authorizations Departmental Access to Data Registrars' office- FERPA Library deadlines
Protocol Reviews Types of Review Exempt Anonymous or identifiable surveys or interviews less than minimal risk Expedited Collection of data from voice, video- less or greater than minimal risk Full board Present more than minimal risks to subjects Studies involving prisoners, persons with undocumented status, research on illegal activities, incarcerated youth, among others
The IRB Protocol Application- Sections What must be included in the IRB protocol application 6. Data Security 7. Potential Risks 8. Affiliations 9. Informed Consent & Assent Forms 10. Study Declaration 1. Research and focus 2. Methods 3. Subjects and Recruitment 4. Data Collection 5. Vulnerable subjects Confidential research participation means that the data from the research subject(s) can potentially be identified or linked to a particular individual. Thus, any data collected face-to-face (consumer survey, focus groups, standing in front of a classroom, collecting IP addresses, etc.) is automatically considered in the category of being confidential A strictly anonymous study design is one in which it is impossible to trace data or information back to the research subject from whom it was obtained. In other words, the data cannot be identified to any research participant, not even by the researcher.
The IRB Protocol Application-Section 2 Methods Summarize the overall design of your proposed study Procedures involving human subjects, including participant observation, as well as up to 100 semi-structured interviews and life histories, will examine the perceived risks or benefits for local community members of proposed mining development projects, as well as past experiences with social and environmental systems under stress from anthropogenic changes to land, territory and resources. The new Lithium Valley project at the Salton Sea, offers an opportunity to lead students in ethnographic field training that combines community-based action research with citizen science.
The IRB Protocol Application-Section 3 Subject and Recruitment A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information. (Dept. of Health and Human Services, 45CFR46) Describe the characteristics of the subject group(s) that will be used in the study. Participants in the study will include Indigenous people, activists, residents, squatters, as well as migrant farmworkers and geothermal plant operators who are 18 years old or older. The subject pool will include members of the California Energy Commission's Lithium Valley Commission, as well as other stakeholders, decision-makers and experts on the role of mining in the energy transition more broadly.
The IRB Protocol Application-Section 6 Data Security The researcher must provide a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information. A strictly anonymous study design is one in which it is impossible to trace data or information back to the research subject from whom it was obtained. In other words, the data cannot be identified to any research participant, not even by the researcher.
The IRB Protocol Application-Section 9 Elements of informed consent include Explanation of the purpose(s) Description of the procedure(s) Summary of the data to be collected Description of any foreseeable risks/ discomforts Description of the benefits to the subject/ including compensation. Explanation of how the investigator (PI) will maintain confidentiality of records. Contact information of all PI s and the IRB office, protocol number A statement that participation is voluntary, that refusal to participate involves no penalty and that the subject may discontinue at any time. Anything else that will help the subject to understand.
Library Resources Subject Librarians https://www.cpp.edu/library/reference-instruction/contact-subject- librarian.shtml https://libguides.library.cpp.edu/datamgmt Workshops (citation, Topic/Research areas and methods) Library Calendar: https://cpp.libcal.com/ Writing Center Website: https://www.cpp.edu/lrc/our-team/writing-center.shtml Bronco Scholar FAQ's: https://www.cpp.edu/library/digital-collections/bronco-scholarworks/faq.shtml Qualtrics https://www.cpp.edu/cba/customer-insights-lab/resources/qualtrics.shtml
IRB checklist Follow a timeline to ensure you are on track Encourage research participation Conduct yourself with integrity Follow University policy and sponsor conditions
QUESTIONS Questions? More info: Human subject research https://www.cpp.edu/research/research-compliance/index.shtml IRB protocol application process https://www.cpp.edu/research/research- compliance/irb/protocol.shtml Irb-office@cpp.edu or 909-869-4215 www.hhs.gov/ohrp/ Members of the IRB-Your college or discipline representative
